MAUDE Adverse Event Report: COOK INC BANDER URETERAL DIVERSION STENT SET; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number 025227-OE

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The user facility reported in email correspondence they have had a few serious incidents where the patient has been affected by the bander ureteral diversion stent set.There is an internal investigation in process.This issue has occurred on at least 3 separate occasions.Requests have been made for additional patient, device and event details.This customer reported at least three (3) incidents.These incidents have been captured in three separate medwatch reports.Please see related mfr.Report numbers 1820334-2017-03243, 1820334-2017-03244 and 1820334-2017-03245.

• Brand Name: BANDER URETERAL DIVERSION STENT SET
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6883267
• MDR Text Key: 87157432
• Report Number: 1820334-2017-03244
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 025227-OE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other